Brief Intervention for Teen Pregnancy Prevention

Teen Pregnancy Prevention Clinical Trial

— TEMPO  

Official title:

Prevention of Teen Pregnancy Through Screening and Brief Intervention in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816424
• Other study ID #: TP2AH000028
• Status: Completed
• Phase: N/A
• Start date: November 11, 2015
• Est. completion date: August 20, 2021

Study information

• Verified date: April 2020
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although the Academy of Pediatrics and the Society for Adolescent Health and Medicine recommend that teen health providers screen for sexual risk behaviors and provide education and counseling to those at risk, there are currently no specific guidelines or protocols available to guide such practices, nor have there been any rigorous evaluations of efficacy. Preventing teen pregnancy through brief intervention in primary care holds the promise to have a significant public health impact and reduce health disparities by engaging, educating, and motivating the majority of teens who visit a primary care setting each year. In the current study, we seek to rigorously evaluate the impact of brief intervention vs. informational control on unprotected sexual intercourse among teens with past year unprotected sex at two primary care clinics serving predominately underserved, minority populations in New Mexico. The target population for the current study will be 1350 male and female teens, aged 13-19, from the Atrisco Center for Family and Community Health and the Albuquerque Job Corps Wellness Center. Extensive formative work involving the study population will be conducted prior to the trial to refine the motivational interviewing-based brief intervention. Eligible youth will be randomly assigned to brief intervention or an informational control condition, in addition to regularly offered medically-based contraception consultation and prescription services. Follow-ups at 3- and 9- months will compare rates of unprotected sex and acceptance of long-acting reversible contraceptives. Brief education and counseling interventions could be feasibly implemented during the greater than eight preventive and acute primary care visits that the average US adolescent attends during their teen years. Such an approach could conserve valuable resources required by more intensive interventions for nonresponsive teens with greater need. Furthermore, social determinants of health, such as poverty and race, that may reduce access to more extensive psychosocial interventions, are less likely to prevent access to primary care, increasing health equity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

• Aged 13-19

• Self-reported past year unprotected sex

• Can read and speak English

• Willing to be contacted for follow-up

Exclusion Criteria:

• Current use of long-acting reversible contraceptives

• Self-reported pregnancy or pregnancy discovered during optional medical contraception consultation

• Expressed suicidality

• Obvious cognitive impairment

• Inability to provide informed consent

Related Conditions & MeSH terms

• Teen Pregnancy Prevention

Intervention

Behavioral:
• Teens Exploring and Managing Prevention Options (TEMPO)

Locations

Country	Name	City	State
United States	The University of New Mexico	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants endorsing unprotected sex at 3 month follow up	All participants	3-Month Endpoint
Primary	Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 3 month follow up	Among female participants	3-Month Endpoint
Secondary	Proportion of participants endorsing unprotected sex at 9 month follow up	All participants	9-Month Endpoint
Secondary	Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 9 month follow up	Among female participants	9-Month Endpoint